ondansetron
- Product NDC
- 53217-300
- 11-digit product format
- 532170300
- Labeler code
- 53217
- Product ID
- 53217-300_9063c4fb-7de3-4a1f-8600-aee07e5c0f77
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ondansetron hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aidarex Pharmaceuticals LLC
- Application
- ANDA077851
- Marketing category
- ANDA
- Marketing start
- 2007-06-25
- Marketing end
- 0000-00-00
- Substance
- ONDANSETRON HYDROCHLORIDE
- Active strength
- 8 mg/1
- Pharmacologic classes
- Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 53217-300-05 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-569b-f424-e053-dadaa90a57ce | Ondansetron, USP |
| 53217-300-06 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-569b-f424-e053-dadaa90a57ce | Ondansetron, USP |
| 53217-300-10 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-569b-f424-e053-dadaa90a57ce | Ondansetron, USP |
| 53217-300-12 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-569b-f424-e053-dadaa90a57ce | Ondansetron, USP |
| 53217-300-13 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-569b-f424-e053-dadaa90a57ce | Ondansetron, USP |
| 53217-300-15 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-569b-f424-e053-dadaa90a57ce | Ondansetron, USP |
| 53217-300-20 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-569b-f424-e053-dadaa90a57ce | Ondansetron, USP |
| 53217-300-30 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-569b-f424-e053-dadaa90a57ce | Ondansetron, USP |
| 53217-300-31 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-569b-f424-e053-dadaa90a57ce | Ondansetron, USP |
| 53217-300-60 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-569b-f424-e053-dadaa90a57ce | Ondansetron, USP |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53217-300-05 | ondansetron | 5 in 1 BOTTLE | TABLET, FILM COATED | 5 | | 1 |
| 53217-300-06 | ondansetron | 6 in 1 BOTTLE | TABLET, FILM COATED | 6 | | 1 |
| 53217-300-10 | ondansetron | 10 in 1 BOTTLE | TABLET, FILM COATED | 10 | | 1 |
| 53217-300-12 | ondansetron | 12 in 1 BOTTLE | TABLET, FILM COATED | 12 | | 1 |
| 53217-300-13 | ondansetron | 4 in 1 BOTTLE | TABLET, FILM COATED | 4 | | 1 |
| 53217-300-15 | ondansetron | 15 in 1 BOTTLE | TABLET, FILM COATED | 15 | | 1 |
| 53217-300-20 | ondansetron | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | | 1 |
| 53217-300-30 | ondansetron | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
| 53217-300-31 | ondansetron | 3 in 1 BOTTLE | TABLET, FILM COATED | 3 | | 1 |
| 53217-300-60 | ondansetron | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53217-300 | ONDANSETRON (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | Legacy NDC, 10 package rows | 20170524_4722ff63-73f6-419e-b193-6af8bc701047.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 53217-300-05 | 53217030005 | 5 in 1 BOTTLE | Historical |
| 53217-300-06 | 53217030006 | 6 in 1 BOTTLE | Historical |
| 53217-300-10 | 53217030010 | 10 in 1 BOTTLE | Historical |
| 53217-300-12 | 53217030012 | 12 in 1 BOTTLE | Historical |
| 53217-300-13 | 53217030013 | 4 in 1 BOTTLE | Historical |
| 53217-300-15 | 53217030015 | 15 in 1 BOTTLE | Historical |
| 53217-300-20 | 53217030020 | 20 in 1 BOTTLE | Historical |
| 53217-300-30 | 53217030030 | 30 in 1 BOTTLE | Historical |
| 53217-300-31 | 53217030031 | 3 in 1 BOTTLE | Historical |
| 53217-300-60 | 53217030060 | 60 in 1 BOTTLE | Historical |